FDA Adverse Event
Malfunction
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
MDR report key: 1220847
·
Received October 28, 2008
Report
- Report Number
- 6000002-2008-09091
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- March 1, 2008
- Report Date
- October 9, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PT REPORTED THE EVENT. UNABLE TO PROVIDE PT'S INFO DUE TO THE HIPPA REGULATIONS. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE IS LEAKING. REPORTEDLY, THIS WAS OBSERVED ON AN ANGIOGRAM. THE PT INDICATED THAT THEY ARE IN CONSTANT PAIN. FOLLOW-UP WITH THE PT INDICATED THAT SHE HAS MODERATE REGURGITATION. REPORTEDLY, THE PT BECAME SYMPTOMATIC IN 2008. THE PT REPORTED THAT THEY ARE TAKING A PRESCRIPTION FOR HIGH BLOOD PRESSURE, AND THE DRUG LIPITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2700 | 3M2007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | LIPITOR |